title: Liposomal daunorubicin versus standard daunorubicin: long term follow-up of the GIMEMA GSI 103 AMLE randomized trial in patients older than 60 years with acute myelogenous leukaemia.
abstract: This randomized phase III clinical trial explored the efficacy of DaunoXome (DNX) versus Daunorubicin (DNR) in acute myeloid leukaemia (AML) patients aged >60 years. Three hundred and one AML patients were randomized to receive DNR (45 mg/m(2) days 1-3) or DNX (80 mg/m(2) days 1-3) plus cytarabine (AraC; 100 mg/m(2) days 1-7). Patients in complete remission (CR) received a course of the same drugs as consolidation and then were randomized for maintenance with AraC+ all trans retinoic acid or no further treatment. Among 153 patients in the DNR arm, 78 (51.0%) achieved CR, 55 (35.9%) were resistant and 20 (13.1%) died during induction. Among 148 patients in the DNX arm, 73 (49.3%) achieved CR, 47 (31.8%) were resistant and 28 (18.9%) died during induction. Univariate analysis showed no difference as to induction results. After CR, DNX showed a higher incidence of early deaths (12.5% vs. 2.6% at 6 months, P = 0.053) but a lower incidence of relapse beyond 6 months (59% vs. 78% at 24 months, P = 0.064), with a cross in overall survival (OS) and disease-free survival (DFS) curves and a later advantage for DNX arm after 12 months from diagnosis. DNX seems to improve OS and DFS in the long-term follow-up, because of a reduction in late relapses.
authors.affiliation: Ematologia, Università La Sapienza, Rome, Italy. rob.lati@libero.it
authors.forename: Roberto
authors.initials: R
authors.lastname: Latagliata
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.forename: Paola
authors.initials: P
authors.lastname: Fazi
authors.forename: Simona
authors.initials: S
authors.lastname: Iacobelli
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martinelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Marco
authors.initials: M
authors.lastname: Sborgia
authors.forename: Francesco
authors.initials: F
authors.lastname: Fabbiano
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Pirrotta
authors.forename: Alfonso
authors.initials: A
authors.lastname: Zaccaria
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Cecilia
authors.initials: C
authors.lastname: Caramatti
authors.forename: Franca
authors.initials: F
authors.lastname: Falzetti
authors.forename: Anna
authors.initials: A
authors.lastname: Candoni
authors.forename: Daniele
authors.initials: D
authors.lastname: Mattei
authors.forename: Monica
authors.initials: M
authors.lastname: Morselli
authors.forename: Giuliana
authors.initials: G
authors.lastname: Alimena
authors.forename: Marco
authors.initials: M
authors.lastname: Vignetti
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003630:Daunorubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D008081:Liposomes; D003630:Daunorubicin